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February 17, 2013

In a significant win for Myriad, and their
licensee Genetic Technologies Ltd, the Australian Federal Court on Friday
upheld Myriad's method patents used in cancer screening for mutations in the
BRCA1 gene. This decision will provide much-needed certainty to gene patent
holders in Australia.

The applicants in the matter, Cancer Voices
Australia and Yvonne D'Arcy, argued that the patents claimed unpatentable
subject matter. The Applicants also argued that the claims covered naturally
occurring DNA, which was not materially different to the DNA that occurs in
nature.

The Court held that the claimed nucleic acid
is "isolated" and so the invention is patentable under Australian
patent law.

The court regarded the claims as not being
directed to naturally occurring nucleic acids as they exist in nature. The
removal of nucleic acid from its natural environment was found to be an
artificial state of affairs and therefore patentable. Basing its reasoning on
well-established Australian case law, the court found that in the absence of
human intervention, naturally occurring nucleic acid does not exist outside the
cell and thus "isolated" nucleic acid does not exist inside the cell.

Recent failed attempts to amend the Patent
Act to exclude gene patents were taken into account. In particular, the
rejection by Parliament of recent proposals that the Patents Bill 1990 be amended to include an exclusion of claims
directed to DNA and RNA. The Court inferred that it was not the intention of
Parliament to exclude gene patenting.

The new experimental use defence incorporated
into the Intellectual Property Laws
Amendment (Raising the Bar) Act 2012 (Cth),effective 16 April 2012, was referred to by the Court. This new
experimental use exemption envisages future research into previously
undiscovered genetic mutations using patented biological materials.

This decision is in line with patent law in
other countries such as the United Kingdom and in the United States where
isolated nucleic acid may be patentable. Myriad's successful appeal in the US
where the Federal Circuit upheld the validity of their patent claims, was noted
by the Court. However, since patent law in Australia is different to that of
the US, the Federal Court based its decision on Australian case law. The
challenge to Myriad's patent was dismissed with costs.

Dr. Longshaw is a Consultant and Senior Member of Wrays Sydney Chemical and Biological Team; Mr. Cox is a Director of Wrays, and practices in life sciences & biotechnology, pharmaceuticals, and medical technologies.

Patent Docs thanks Wrays for providing one of two views on the Cancer Voices Australia decision that we are able to pass along to our readers.